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Medical Areas: Nephrology | Family Medicine | Urology
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Anturol (oxybutynin) Gel
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Antares Pharma
Approval Status: Approved December 2011
Treatment Area: overactive bladder
Anturol is a topical gel formulation of the muscarinic ACh antagonist oxybutynin, based on Antares' Advanced Transdermal Delivery (ATD) technology platform. Oxybutynin results in relaxation of bladder smooth muscle. In patients with conditions characterized by involuntary detrusor contractions, oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.
Anturol is specifically indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Anturol gel is supplied in a metered dose pump for toplical administration. The recommended dosage is three pumps (84 mg/day) applied once daily to clean, dry, intact skin on the abdomen, or upper arms/shoulders, or thighs.
The FDA approval of Anturol was based on a single randomized, double-blind, placebo-controlled, multicenter 12-week study. The trial enrolled approximately 620 subjects with urinary frequency and urge and mixed urinary incontinence with a predominance of urge incontinence episodes. The subjects were either treatment-naïve or had demonstrated a beneficial response to anticholinergic treatment for OAB. The subjects received 84 mg/day oxybutynin, 56 mg/day oxybutynin, or placebo. The primary efficacy endpoint was the change from baseline to week 12 in the number of urinary incontinence episodes (UIE) per week, as determined from a 3-day patient daily diary. Subjects treated with Anturol (84 mg) experienced a statistically significant decrease in the number of UIE per week from baseline to endpoint compared with placebo (p=0.0445). Subjects treated with the 56 mg dose did not show statistically significant efficacy. Statistically significant improvements in daily urinary frequency (p=0.0010) and urinary void volume (p<0.0001) were also seen with Anturol (84 mg) relative to placebo. The mean difference from placebo for Anturol (84 mg) was -2.3 for urinary incontinence episodes per week in a group of subjects with a mean of greater than 40 incontinence episodes per week at baseline.
Adverse events associated with the use of Anturol may include, but are not limited to, the following:
- dry mouth
- application site reactions (erythema, rash, pruritus)
- dry eyes
- blurred vision
Mechanism of Action
Oxybutynin is an antispasmodic, antimuscarinic agent. It acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. Oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.
For additional information regarding Anturol or overactive bladder, please visit the Anturol web page.